NCT02727699

Who might be able to join this trial:

• You are 50 years of age or older
• You have been diagnosed with mild Alzheimer's disease, with signs of getting worse in the 6 months before screening, as confirmed by your doctor using recognised medical guidelines
• Your memory and thinking test score (called MMSE) is between 20 and 26 out of 30
• Your overall dementia severity rating (called CDR) is between 0.5 and 1.0
• You have had a brain scan (MRI or CT) in the past 12 months that your doctor believes is consistent with Alzheimer's disease and shows no other significant problems
• You are either already taking a stable dose of Alzheimer's medication (such as donepezil or memantine) for at least 3 months, or you are not taking any such medication at all
• Apart from your Alzheimer's diagnosis, your doctor considers you to be in generally good health
• You have a trusted person (such as a family member or carer) who sees you regularly, can attend all study visits in person, and can give accurate information about how you are doing
• You are willing and able to follow all the study requirements for the full duration of the trial
• If you are a woman who has gone through menopause (no periods for 12 months), you may be eligible — this may be confirmed by a hormone blood test (FSH level above 40 mIU/mL)
• If you are a woman who could still become pregnant, you must have a negative pregnancy test at the start, not be breastfeeding, and agree to use highly effective contraception from screening until 3 months after your last dose of study medication
• If you are a woman who has had a hysterectomy, removal of both ovaries, or both fallopian tubes, you may be eligible
• If you are a man who is sexually active and your partner could become pregnant, you must agree to use highly effective contraception from the first dose until 3 months after your last dose of study medication
• You must give written consent to take part in the study

Who may not be able to join:

• You have significantly abnormal results for blood pressure, heart rate, breathing rate, or temperature, as judged by your doctor
• You have significantly abnormal blood or urine test results, including problems with liver or kidney function, or low Vitamin B12 levels
• You have had a serious illness or infection in the 4 weeks before joining the study
• You have a significant neurological condition other than Alzheimer's, such as Parkinson's disease, Huntington's disease, brain tumour, multiple sclerosis, epilepsy, or a history of serious head injury with lasting effects
• You have signs of nerve damage in your body (peripheral neuropathy) or abnormal nerve conduction test results
• You have had a stroke in the year before joining the study
• You have ever been diagnosed with a major psychiatric condition such as schizophrenia, bipolar disorder, alcohol dependence, or major depression
• You have a history of a condition affecting the hypothalamus, pituitary gland, or adrenal glands (confirm with trial site)
• You have uncontrolled problems with blood sugar or cholesterol/fat levels
• You have a significantly abnormal heart tracing (ECG), including a specific measurement called QTc being above 450 ms
• You are taking any medications that are not allowed under the study rules (confirm with trial site)
• You have taken part in another clinical trial involving an experimental drug or device in the 60 days before screening
• You are not able to communicate well in English, as the tests used in this study are only available in English
• You are currently doing the same memory and thinking tests used in this study as part of another study or external assessment, which could affect the results
• You have eaten or drunk anything containing grapefruit, Seville oranges, or star fruit (including juices) in the 3 days before your first dose of study medication

Important: Always verify eligibility with the trial site directly before applying.